FSP Senior CRA
Core
Conduct remote and on-site clinical monitoring for complex oncology and cell/gene therapy studies to ensure protocol compliance, data accuracy, and site management.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for oncology and advanced therapy studies
Domain
Biopharmaceuticals / Oncology / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring (RBM), root cause analysis, ICH-GCP regulations, investigational product handling, audit readiness, site qualification
Preferred skills
Early phase trial management, advanced therapy study experience
Technologies
Veeva eTMF, CTMS, EDC
Responsibilities
Monitor investigator sites using risk-based approaches; review source data and case report forms; assess investigational product handling; document observations and escalate deficiencies; maintain contact with sites for protocol adherence; support site initiation, qualification, and close-out; contribute to audit and inspection readiness.
Seniority
Senior, hands-on IC
